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Control of Myopia Using Novel Spectacle Lens Designs (CYPRESS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03623074
Recruitment Status : Active, not recruiting
First Posted : August 9, 2018
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
SightGlass Vision, Inc.

Brief Summary:
Randomized, controlled, multisite, subject-and observer-masked, 3-arm parallel group clinical trial of 36-month duration to evaluate the safety and efficacy of a novel spectacle lens design in reducing the progression of juvenile myopia.

Condition or disease Intervention/treatment Phase
Juvenile Myopia Device: Novel spectacle lens design Device: Spectacle lenses Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 266 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants and parents of participants will be masked. Investigational site staff tasked with measuring key primary variables (i.e., axial length and SER) will be masked.
Primary Purpose: Treatment
Official Title: Efficacy and Safety Study of Novel Spectacle Lens Designs to Control of Myopia
Actual Study Start Date : July 16, 2018
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: Test Arm 1
Single vision, impact-resistant spectacle lenses
Device: Novel spectacle lens design
Use of lenses may reduce the rate of progression of juvenile myopia

Experimental: Test Arm 2
Single vision, impact-resistant spectacle lenses
Device: Novel spectacle lens design
Use of lenses may reduce the rate of progression of juvenile myopia

Test Arm 3
Single vision, impact-resistant spectacle lenses
Device: Spectacle lenses
Use of lenses may reduce the rate of progression of juvenile myopia




Primary Outcome Measures :
  1. Axial length [ Time Frame: 36 Months ]
    Change in axial length from baseline

  2. Spherical equivalent refraction [ Time Frame: 36 Months ]
    Change in spherical equivalent refraction from baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children 6-10 years of age (day prior to 10th birthday) at time of informed consent/assent
  • SER error between -0.75 and -4.50 D
  • SER power between the two eyes must be less than or equal to 1.50 D
  • Willingness to participate in the trial for 3 years without content lens wear

Exclusion Criteria:

  • Previous or current use of contact lenses
  • Previous or current use of bifocals, progressive addition spectacles lenses
  • Previous or current use of myopia control treatment
  • Astigmatism worse then -1.25 DC in either eye

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03623074


Locations
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United States, California
Golden Optometric Group
Whittier, California, United States, 90606
United States, Florida
Sabal Eye Care
Longwood, Florida, United States, 32779
Visual Performance Center
Pensacola, Florida, United States, 32503
United States, Kansas
Kannarr Eye Care
Pittsburg, Kansas, United States, 66762
United States, Louisiana
Eye Associates of Northeast Louisiana (DBA Haik Humble Eye Center) Research Dept
West Monroe, Louisiana, United States, 71291
United States, Missouri
Advanced Eyecare, PC
Raytown, Missouri, United States, 64133
United States, New York
SUNY School of Optometry
New York, New York, United States, 10036
Sacco Eye Group
Vestal, New York, United States, 13850
Dept of Clinical Research, South Shore Eye Care, LLP
Wantagh, New York, United States, 11793
United States, South Dakota
Dunes Eye Consultants
Dakota Dunes, South Dakota, United States, 57049
United States, Tennessee
Total Eye Care
Memphis, Tennessee, United States, 38119
United States, Texas
University of Houston College of Optometry
Houston, Texas, United States, 77204
United States, Utah
William J Bogus, OD, FAAO
Salt Lake City, Utah, United States, 84106
Canada, Ontario
Center for Ocular Research & Education, School of Optometry, University of Waterloo School of Optometry & Vision Science
Waterloo, Ontario, Canada, N2L 3G1
Sponsors and Collaborators
SightGlass Vision, Inc.
Investigators
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Study Chair: Joseph Rappon, OD, MS, FAAO SightGlass Vision, Inc.

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Responsible Party: SightGlass Vision, Inc.
ClinicalTrials.gov Identifier: NCT03623074     History of Changes
Other Study ID Numbers: CPRO-1802-001
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by SightGlass Vision, Inc.:
Myopia

Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases